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Hycodan

These highlights do not include all the information needed to use HYCODAN safely and effectively. See full prescribing information for HYCODAN. HYCODAN (hydrocodone bitartrate and homatropine methylbromide) tablets, for oral use, CII HYCODAN (hydrocodone bitartrate and homatropine methylbromide) oral solution, CII Initial U.S. Approval: 1943

Approved
Approval ID

901d4115-f71a-4681-bd0e-c9b691151b78

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 29, 2021

Manufacturers
FDA

Genus Lifesciences Inc.

DUNS: 113290444

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Hydrocodone Bitartrate and Homatropine Methylbromide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code64950-205
Application NumberNDA005213
Product Classification
M
Marketing Category
C73594
G
Generic Name
Hydrocodone Bitartrate and Homatropine Methylbromide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 3, 2021
FDA Product Classification

INGREDIENTS (8)

homatropine methylbromideActive
Quantity: 1.5 mg in 1 1
Code: 68JRS2HC1C
Classification: ACTIB
hydrocodone bitartrateActive
Quantity: 5 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
Dibasic Calcium Phosphate DihydrateInactive
Code: O7TSZ97GEP
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Stearic AcidInactive
Code: 4ELV7Z65AP
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT

Hydrocodone Bitartrate and Homatropine Methylbromide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code64950-342
Application NumberNDA005213
Product Classification
M
Marketing Category
C73594
G
Generic Name
Hydrocodone Bitartrate and Homatropine Methylbromide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 3, 2021
FDA Product Classification

INGREDIENTS (11)

anhydrous citric acidInactive
Code: XF417D3PSL
Classification: IACT
homatropine methylbromideActive
Quantity: 1.5 mg in 5 mL
Code: 68JRS2HC1C
Classification: ACTIB
FD&C red no. 40Inactive
Code: WZB9127XOA
Classification: IACT
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
CHERRYInactive
Code: BUC5I9595W
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
hydrocodone bitartrateActive
Quantity: 5 mg in 5 mL
Code: NO70W886KK
Classification: ACTIB

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Hycodan - FDA Drug Approval Details